Shimadzu Medical Systems recalls D150GC-40 Digital Angiography System generators due to potential x-ray radiation dose rate exceeding safety limits in fluoroscopic mode. Affected units have specific serial numbers.
Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.
Shimadzu Medical Systems is recalling their D150GC-40 Digital Angiography System generators because improper installation could cause x-ray radiation to exceed safe levels during fluoroscopy. This poses a risk of unnecessary radiation exposure to users and patients.
The generator's installation criteria are inadequate, which may cause the x-ray radiation dose rate to exceed safe limits when used in fluoroscopic mode. This could lead to unnecessary radiation exposure for patients and medical personnel during imaging procedures.
Healthcare facilities using the D150GC-40 generator model are most at risk. Patients and medical staff during procedures using this system could receive higher-than-intended radiation exposure.
Check for the D150GC-40 generator model. Affected units have serial numbers ranging from 3M99D44446001 to LM99D44B8001, with specific SMS IDs listed in the recall notice.
Identify the serial number on your generator to see if it matches the affected range: 3M99D44446001 to LM99D44B8001.
The generator's installation criteria are inadequate, which may cause x-ray radiation dose rates to exceed safe limits during fluoroscopic imaging.
Check your generator's serial number against the affected range provided in the recall notice to determine if it's included.
The recall notice does not specify a remedy or corrective action.
We’ve drafted a message you can send Shimadzu Trinias to request your refund or repair — edit it as you like.
Subject: Recall Z-0655-2022 — Shimadzu Trinias Shimadzu Trinias Hello, I own a Shimadzu Trinias that is covered by recall Z-0655-2022 from Shimadzu Trinias. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
